US9888867B2 - Medical breathing apparatus - Google Patents

Medical breathing apparatus Download PDF

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Publication number
US9888867B2
US9888867B2 US14/213,719 US201414213719A US9888867B2 US 9888867 B2 US9888867 B2 US 9888867B2 US 201414213719 A US201414213719 A US 201414213719A US 9888867 B2 US9888867 B2 US 9888867B2
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patient
lateral interocclusal
mouthpiece
posterior
passageway
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US14/213,719
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US20140276170A1 (en
Inventor
Timothy Hestness
Robert Moore
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Airway Control Technologies LLC
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Airway Control Technologies LLC
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Assigned to AIRWAY CONTROL TECHNOLOGIES, LLC. reassignment AIRWAY CONTROL TECHNOLOGIES, LLC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HESTNESS, Timothy, MOORE, ROBERT
Publication of US20140276170A1 publication Critical patent/US20140276170A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/097—Devices for facilitating collection of breath or for directing breath into or through measuring devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/24—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the mouth, i.e. stomatoscopes, e.g. with tongue depressors; Instruments for opening or keeping open the mouth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/083—Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
    • A61B5/0833—Measuring rate of oxygen consumption
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A61B5/083—Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption
    • A61B5/0836—Measuring rate of CO2 production
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C5/00—Filling or capping teeth
    • A61C5/90—Oral protectors for use during treatment, e.g. lip or mouth protectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0488—Mouthpieces; Means for guiding, securing or introducing the tubes
    • A61M16/049—Mouthpieces
    • A61M16/0493—Mouthpieces with means for protecting the tube from damage caused by the patient's teeth, e.g. bite block
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A61F5/566—Intra-oral devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0816—Joints or connectors
    • A61M16/0841—Joints or connectors for sampling
    • A61M16/085—Gas sampling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0208—Oxygen
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0266—Nitrogen (N)
    • A61M2202/0283—Nitrous oxide (N2O)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation
    • A61M2230/432—Composition of exhalation partial CO2 pressure (P-CO2)
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02C—CAPTURE, STORAGE, SEQUESTRATION OR DISPOSAL OF GREENHOUSE GASES [GHG]
    • Y02C20/00—Capture or disposal of greenhouse gases
    • Y02C20/10—Capture or disposal of greenhouse gases of nitrous oxide (N2O)

Definitions

  • the present invention pertains to medical devices and methods for using medical devices. More particularly, the present invention pertains to medical devices for respiratory support.
  • a wide variety of devices have been developed for medical use, for example, use in the mouth or respiratory system. Some of these devices include oral appliances, oral or nasal cannulas, breathing or ventilation tubes, and the like. These devices may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for using medical devices.
  • a medical mouthpiece may include a generally U-shaped member forming an upper surface configured to contact an upper dentition of a patient spaced apart from a lower surface configured to contact a lower dentition of the patient, wherein the U-shaped member forms a lateral interocclusal passageway extending from an anterior aperture to a posterior aperture between the upper surface and the lower surface, the lateral interocclusal passageway configured to provide a conduit for respiratory gas exchange.
  • a medical mouthpiece may include a generally U-shaped member forming an upper surface configured to contact an upper dentition of a patient spaced apart from a lower surface configured to contact a lower dentition of the patient, a sampling port formed within a posterior portion of the generally U-shaped member, the sampling port having a sampling orifice recessed within the posterior portion which in some, but not all, embodiments may be facing in a posterior direction, and a sampling conduit for fluid communication between the sampling port and an analyzing apparatus configured to analyze exhaled respiratory gases.
  • a medical mouthpiece may include a generally U-shaped member forming an upper surface configured to contact an upper dentition of a patient spaced apart from a lower surface configured to contact a lower dentition of the patient, and a supplemental gas conduit for fluid communication between a source of supplemental gas and a supply orifice formed in the generally U-shaped member.
  • a medical mouthpiece may include a generally U-shaped member forming an upper surface configured to contact an upper dentition of a patient spaced apart from a lower surface configured to contact a lower dentition of the patient, wherein the U-shaped member forms a lateral interocclusal passageway extending from an anterior aperture to a posterior aperture between the upper surface and the lower surface, the lateral interocclusal passageway configured to provide a conduit for respiratory gas exchange, a sampling port formed within a posterior portion of the lateral interocclusal passageway and may have a sampling orifice that may be facing in a posterior direction, the sampling port configured to be positioned in a posterior portion of a lateral interocclusal space of the patient, a sampling conduit for fluid communication between the sampling port and an analyzing apparatus configured to analyze exhaled respiratory gases, and a supplemental gas conduit for fluid communication between a source of supplemental gas and a supply orifice within the lateral interocclusal passageway.
  • a medical mouthpiece may include a generally U-shaped member forming an upper surface configured to contact an upper dentition of a patient spaced apart from a lower surface configured to contact a lower dentition of the patient, wherein the U-shaped member forms a lateral interocclusal passageway extending from an anterior aperture to a posterior aperture along an axis defined by a line between the upper dentition and the lower dentition, the lateral interocclusal passageway configured to provide a conduit for respiratory gas exchange, a sampling port formed within a posterior portion of the lateral interocclusal passageway and may have a sampling orifice that may be facing in a posterior direction, a sampling conduit fluidly connecting the sampling port and an analyzing apparatus configured to analyze exhaled respiratory gases collected adjacent the oropharynx of the patient, and a supplemental gas conduit fluidly connecting a source of supplemental gas and a supply orifice within the lateral interocclusal passageway.
  • a medical mouthpiece may include a generally U-shaped first member forming an upper channel spaced apart from a lower channel with left and right lateral interocclusal passageways formed therebetween, the left and right lateral interocclusal passageways extending from an anterior portion of the first member through a posterior portion of the first member, and a first central orifice extending through the anterior portion, wherein the first member is shaped and configured to receive an upper dentition of a patient in the upper channel or a lower dentition of a patient in the lower channel, and a second member attached to the anterior portion, the second member including a second central orifice extending through the second member and in communication with the first central orifice to form a central passageway extending through the mouthpiece, wherein the second member includes a first port and a second port formed therein, the first port being fluidly connected to a left lateral interocclusal sampling port and a right lateral interocclusal sampling port for sampling expiration gases, the left and right lateral interocclusal sampling ports being disposed
  • a method for delivering a gas to a patient may include inserting a mouthpiece into a mouth of a patient, the mouthpiece having a generally U-shaped member forming a lateral interocclusal passageway extending posteriorly between an upper dentition and a lower dentition of the patient, and delivering a gas to the patient through the lateral interocclusal passageway such that the gas is delivered through a posterior aperture to a space adjacent the patient's posterior oropharynx.
  • FIG. 1 is a partial side view of mouth anatomy
  • FIG. 2 is a partial front view of mouth anatomy
  • FIG. 3 is a front perspective view of an example mouthpiece
  • FIG. 4 is a rear perspective view of an example mouthpiece
  • FIG. 5 is a partially exploded perspective view of an example mouthpiece
  • FIG. 6 is a partial cross-sectional side view of an example mouthpiece
  • FIG. 7 is a top view of an example mouthpiece
  • FIG. 8 is a bottom view of an example mouthpiece
  • FIG. 9 is a partial side view of an example mouthpiece disposed within mouth anatomy.
  • the “oral cavity” may be defined as the cavity of the mouth, particularly the part of the mouth behind the gums and teeth that is bounded above by the hard and soft palates and below by the tongue and by the mucous membrane connecting it with the inner part of the mandible.
  • a “dentition” refers to a character of a set of teeth, particularly with respect to number, kind, and/or arrangement.
  • the teeth of the upper jaw or maxilla may be referred to as the “upper dentition” and the teeth of the lower jaw or mandible may be referred to as the “lower dentition”.
  • interocclusal refers to the space situated between the occlusal surfaces of opposing teeth in the two dental arches.
  • the interocclusal space may be considered to encompass the vertical (i.e., superior-inferior) space between the upper dentition or teeth and the lower dentition or teeth.
  • the interocclusal space may be further separated into an anterior interocclusal space generally situated between the upper and lower incisors or front teeth of the two dental arches, and a lateral interocclusal space (or spaces) generally situated outside or on either side of the upper and lower incisors and/or between the upper and lower molars of the two dental arches.
  • the lateral interocclusal space may lie generally along a line or axis following or aligned with the molars.
  • the “buccal cavity” may be considered to represent the area of the mouth located between the teeth and cheeks.
  • numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated.
  • the term “about”, in the context of numeric values, generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure. Other uses of the term “about” (i.e., in a context other than numeric values) may be assumed to have their ordinary and customary definition(s), as understood from and consistent with the context of the specification, unless otherwise specified.
  • Weight percent, percent by weight, wt %, wt-%, % by weight, and the like are synonyms that refer to the concentration of a substance as the weight of that substance divided by the weight of the composition and multiplied by 100.
  • references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc. indicate that the embodiment(s) described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it would be within the knowledge of one skilled in the art to effect such feature, structure, or characteristic in connection with other embodiments, whether or not explicitly described, unless clearly stated to the contrary.
  • the upper and lower jaws may include an upper dentition 10 and a lower dentition 20 , respectively.
  • each of the upper dentition 10 and the lower dentition 20 may include four incisors located at the front or anterior portion of the dentition and up to three molars located at a rear or posterior portion of the dentition.
  • the third or most posterior molar may be called the wisdom tooth, and is sometimes removed for various reasons.
  • the dentition may include two canines or cuspids, with one canine located on each side (outside or laterally) of the four incisors.
  • Two premolars or bicuspids may be disposed between the canines and the molars along the dentition. Each dentition forms a generally U-shaped arrangement.
  • the space between the upper dentition 10 and the lower dentition 20 may be referred to as the interocclusal space 40 . More specifically, the interocclusal space located between the incisors of the upper dentition 10 and lower dentition 20 may be called the anterior interocclusal space, while the interocclusal space located laterally of the incisors and extending generally anteriorly to posteriorly between the premolars and/or the molars of the upper dentition 10 and the lower dentition 20 may be called the lateral interocclusal space.
  • the lateral interocclusal space may be bilateral and may accordingly include a left lateral interocclusal space and a right lateral interocclusal space each corresponding to an appropriate side of the patient's anatomy.
  • Located at the rear of the mouth, and disposed on either side of the opening into the throat are the left and right anterior tonsillar pillars 32 .
  • the entrance to the throat from the mouth, and the space in the throat at the upper portion of the pharynx may generally be referred to as the oropharynx 30 .
  • the rear or posterior wall of the oropharynx is the portion of the throat which may be visibly seen at the back of the throat (behind the uvula) when viewing into a patient's mouth.
  • the oral cavity 50 may be seen in FIG. 2 as the central space between the molars and posterior of the incisors of the lower dentition 20 .
  • the oral cavity 50 may extend superiorly from the tongue 52 to the palate or roof of the mouth, and so occupies the central space between the molars and posterior of the incisors of the upper dentition 10 , also.
  • the interocclusal space 40 includes the vertical (superior-inferior) space formed between the upper dentition 10 and the lower dentition 20 when the jaw is opened.
  • FIGS. 3-8 illustrate an example medical mouthpiece 100 .
  • the mouthpiece 100 may be generally sized and/or shaped to fit within the anatomy of a patient's mouth.
  • the mouthpiece 100 may be a single, monolithic, or unitary structure, or may be made of multiple parts and/or components.
  • the mouthpiece 100 may include a generally U-shaped first member or portion 110 and a second member or portion 180 attached to the first member 110 .
  • the first and second portions may be separate components and/or pieces, as illustrated, but in some embodiments, the first portion or member 110 and the second portion or member 180 may be integrally formed as a single member or piece.
  • first member 110 and the second member 180 may be formed as separate pieces and later assembled together to form the mouthpiece 100 .
  • the first member 110 may be attached, connected, or otherwise coupled to the second member 180 using any appropriate means including, but not limited to, adhesive bonding, mechanical fastener(s), welding, snap fit, interference fit, friction fit, or other suitable means.
  • the first member 110 may be detachable from the second member 180 .
  • the second member 180 may include a first port 182 and a second port 184 .
  • the use, function, and structural connectivity of the first port 182 and the second port 184 will become apparent in the discussion below.
  • the second member 180 may include a central orifice 188 extending therethrough to form a portion 186 of the central passageway extending anteriorly to posteriorly through the mouthpiece 100 .
  • the first member 110 may include an anterior central orifice 128 and a posterior central orifice 130 . A portion 126 of the central passageway extends through the anterior portion of the first member 110 from the anterior central orifice 128 to the posterior central orifice 130 .
  • the central passageway may be formed within the first member 110 alone.
  • the central passageway may be configured to permit access to the oral cavity 50 when the mouthpiece 100 is positioned in the mouth of the patient.
  • the central orifice 188 and/or the anterior central orifice 128 may be positioned exterior to the mouth of the patient, as seen for example in FIG. 9 .
  • a medical instrument such as a suction device, an endoscope, an endotracheal tube, etc., for example, may be introduced into the oral cavity 50 through the central passageway as needed or desired.
  • the first member or portion 110 may be generally U-shaped and may form or include an upper surface configured to contact the upper dentition 10 of a patient and/or a lower surface configured to contact the lower dentition 20 of a patient.
  • the upper surface may be spaced apart from the lower surface.
  • the upper surface forms an upper channel 112 configured to receive the upper dentition 10 .
  • the lower surface forms a lower channel 114 configured to receive the lower dentition 20 .
  • An anterior portion of the first member 110 may include a portion of the upper and lower surfaces or channels 112 / 114 extending transversely (left and/or right from the medial line) between the lateral interocclusal passageways 116 (described in more detail below) to form or act as a bite block configured to be positioned between the incisors of the upper dentition 10 and the lower dentition 20 .
  • the central passageway may terminate at the posterior central orifice 130 proximate a posterior portion of the upper and lower channels 112 / 114 extending transversely between the left and right lateral interocclusal passageways 116 .
  • the upper surface (or an inferior surface of the upper channel 112 ) and the lower surface (or a superior surface of the lower channel 114 ) may angle toward each other in a posterior direction. In other words, the upper surface and the lower surface may be closer together at a posterior portion of the first member 110 than at an anterior portion of the first member 110 .
  • the first member 110 forms a lateral interocclusal passageway 116 extending from an anterior aperture 118 to a posterior aperture 120 .
  • the upper surface and the lower surface may be spaced apart by the lateral interocclusal passageway 116 .
  • the first member 110 may form two (i.e., left and right) lateral interocclusal passageways 116 configured to be positioned within the lateral interocclusal space(s) 40 and/or disposed on opposing sides of the oral cavity 50 .
  • the lateral interocclusal passageway(s) 116 may be configured to provide a conduit for respiratory gas exchange (i.e., breathing).
  • the cross-sectional area (i.e., size and/or shape) of the lateral interocclusal passageway(s) 116 may be generally sufficient to allow adequate ventilation to the patient.
  • the interocclusal passageway(s) 116 either each individually and/or collectively, may be dimensioned to have a minimum cross sectional open pathway area in the range of about 15 to about 170 mm 2 , for example in the range of about 50 to about 150 mm 2 , for example in the range of about 80 to about 140 mm 2 . These ranges are believed to provide an adequate fluid pathway or conduit for respiratory gas exchange exclusively through the lateral interocclusal passageway(s) 116 within the device for most patients, but other sizes and/or ranges are contemplated for specific applications, for example, individual patient needs.
  • the anterior aperture 118 and/or the lateral interocclusal passageway(s) 116 may be fluidly and/or operatively connected to a ventilator or pressure device 200 , for example as seen in FIG. 9 , configured to deliver continuous or intermittent positive pressure to the posterior aperture 120 , thereby delivering a respiratory gas (e.g., air) to a space adjacent the oropharynx 30 for inspiration by the patient.
  • a respiratory gas e.g., air
  • the anterior aperture 118 when the mouthpiece 100 is positioned in the mouth of the patient, the anterior aperture 118 may be positioned exterior to the mouth of the patient.
  • the anterior aperture 118 may be configured to connect to known or existing airway connectors and/or devices, such as ventilator equipment, CPAP machines, nebulizers, and the like.
  • the left and right lateral interocclusal passageways 116 may be configured or formed to combine into a single passageway for connection to an external airway connector or device.
  • an adapter is contemplated that may connect to both anterior apertures 118 of the left and right lateral interocclusal passageways 116 that may combine or reduce the passageways to a single external conduit with a single external opening or connector.
  • the posterior aperture 120 is configured to avoid delivering a gas directly onto the tongue 52 of the patient. In some embodiments, the posterior aperture 120 is configured to avoid delivering a gas directly onto a cheek or directly into the buccal cavity of the patient. In some embodiments, the posterior aperture 120 is configured to deliver a gas through the lateral interocclusal space 40 of the patient. In some embodiments, the posterior aperture 120 is configured to deliver a gas to the posterior oropharynx 30 of the patient without eliciting a gag reflex. In some embodiments, the posterior aperture 120 is configured to deliver a gas to the posterior oropharynx 30 of the patient without stimulating salivation.
  • the first member 110 may include a sampling port 150 formed within a posterior portion of the lateral interocclusal passageway(s) 116 .
  • each lateral interocclusal passageway 116 may include a sampling port 150 and orifice 152 (i.e., a left lateral interocclusal sampling port and a right lateral interocclusal sampling port) formed therein.
  • the sampling port 150 may include a sampling orifice 152 facing in a posterior direction toward the posterior aperture 120 .
  • the port 150 may be facing in other directions, such as angled or facing laterally, medially, superiorly, inferiorly, or the like, or any combination thereof or angle desired.
  • the sampling port 150 and orifice 152 may be recessed from the posterior aperture 120 within the lateral interocclusal passageway 116 . In some embodiments, the sampling port 150 may be generally flush with or otherwise positioned at or within the posterior aperture 120 . In some embodiments, the sampling port 150 and/or the sampling orifice 152 may include a covering or valve disposed thereon. The covering or valve may be gas permeable to permit exhaled respiratory gases to pass therethrough, while being liquid impermeable to prevent liquids such as saliva or other oral secretions from entering the sampling port 150 and/or the sampling orifice 152 . In some embodiments, the first member 110 may be configured to position the posterior aperture 120 and/or the sampling port 150 between a posterior edge of the second molar and the anterior tonsillar pillar 32 , as may be seen in FIG. 9 for example.
  • the sampling port 150 may be in fluid communication with and/or fluidly connected to a first port 182 and/or an analyzing apparatus 300 by a sampling conduit 154 .
  • the analyzing apparatus 300 may be operatively connected to the first port 182 and/or the sampling port 150 , as seen for example in FIG. 9 .
  • the sampling conduit 154 may include a discrete tubular member embedded or molded within the first member 110 , a passageway or lumen integrally formed or molded within the first member 110 , and/or a combination thereof.
  • the sampling conduit 154 may extend externally of the mouthpiece 100 , either as an integral element or as a separate tubing or conduit element fluidly connected to the first port 182 , to the analyzing apparatus 300 .
  • the analyzing apparatus 300 may be any suitable apparatus known in the art for analyzing and/or monitoring exhaled respiratory gases for, but not limited to, end tidal carbon dioxide (ETCO2) concentration, for example.
  • the analyzing apparatus 300 may compare, plot, chart, or otherwise record data such as, for example, end tidal carbon dioxide (ETCO2) concentration as a function of time.
  • the first port 182 may be formed in the second member 180 . While not expressly shown, in some embodiments, the first port 182 may be formed in the first member 110 . In some embodiments, there may be no first port 182 , and the sampling conduit 154 may extend directly from the sampling port 150 to the analyzing apparatus 300 . In some embodiments, the first port 182 may act or function as a connector between a portion of the sampling conduit 154 disposed internal to the mouthpiece 100 and a separate, external portion of the sampling conduit 154 , for example a section of tubular hose connecting the analyzing apparatus 300 to the first port 182 .
  • the first member 110 may include a supply orifice 140 formed within the lateral interocclusal passageway 116 and a supplemental gas conduit 144 in fluid communication with and/or fluidly connected to a second port 184 and/or a source of supplemental gas 400 , for example, oxygen, nitrous oxide, an aerosolized pharmaceutical, or other suitable gas.
  • supplemental gas 400 for example, oxygen, nitrous oxide, an aerosolized pharmaceutical, or other suitable gas.
  • the source of supplemental gas 400 may be operatively connected to the second port 184 and/or the supply orifice 140 , as seen for example in FIG. 9 .
  • each lateral interocclusal passageway 116 may include a supply orifice 140 (i.e., a left lateral interocclusal supply orifice and a right lateral interocclusal supply orifice) formed therein.
  • the supply orifice 140 may be configured to deliver a supplemental gas into the lateral interocclusal passageway 116 .
  • the supplemental gas may be delivered at a flow rate of about 0.1 liters per minute to about 15 liters per minute.
  • the first member 110 may include both a supply orifice 140 and a sampling port 150 , along with any additional structure associated with each (i.e., the supplemental gas conduit 144 , the sampling conduit 154 , etc.).
  • the supply orifice 140 is disposed or located anteriorly of the sampling port 150 .
  • supplemental gas can be delivered to the lateral interocclusal passageway for inspiration by the patient without diluting exhaled respiratory gases being collected at the sampling port 150 .
  • exhaled respiratory gases are expelled through the lateral interocclusal passageway 116 in a posterior to anterior direction, and any supplemental gas flowing through the supply orifice 140 is expelled away from the sampling port with the exhaled respiratory gases.
  • exhaled respiratory gases may be collected at the sampling port 150 which are not diluted by the supplemental gas.
  • a method for delivering a gas to a patient may include inserting a mouthpiece into a mouth of a patient, the mouthpiece having a generally U-shaped member forming a lateral interocclusal passageway extending posteriorly between an upper dentition and a lower dentition of the patient. After inserting the mouthpiece, the method may include delivering a gas to the patient through the lateral interocclusal passageway such that the gas is delivered through a posterior aperture to a space adjacent the patient's posterior oropharynx.
  • the mouthpiece may include a supplemental gas conduit in fluid communication with the lateral interocclusal passageway, and the method may further include delivering a supplemental gas through the supplemental gas conduit and into the lateral interocclusal passageway, the supplemental gas mixing with the gas and being delivered to the patient's posterior oropharynx.
  • the may include a sampling port disposed within a posterior portion of the lateral interocclusal passageway, and a sampling conduit fluidly connecting the sampling port to an analyzing apparatus, and the method may further include collecting a sample of exhaled respiratory gases at the sampling port, and analyzing the sample for end tidal carbon dioxide (ETCO2) concentration.
  • the method may further include plotting the end tidal carbon dioxide (ETCO2) concentration as a function of time.
  • the structure and/or methods described above, and in particular the lack of structure disposed within the oral cavity, may reduce or eliminate intra-oral bulk commonly found in prior oral appliances that may displace the tongue posteriorly within the oral cavity which may contribute to or increase airway obstruction.
  • the mouthpiece described herein alone or when combined with positive airway pressure delivered through the lateral interocclusal passageway(s) to the oropharynx, may relieve or improve airway obstruction by displacing the tongue anteriorly, or permitting the tongue to move anteriorly due to lack of bulk preventing such movement, which may increase the glossopharyngeal space and/or open the oropharynx.
  • a mandibular advancement device may be incorporated into the mouthpiece 100 .
  • supplemental gas can be delivered posteriorly, closer to the oropharynx without the adverse effects of intra-oral devices or structures such as eliciting a gag reflex, stimulation of salivation, and/or displacing the tongue posteriorly.
  • delivering oxygen near the oropharynx may increase the opportunity for entraining supplemental oxygen independent of whether oral or nasal breathing is taking place.
  • Delivery of oxygen and/or positive pressure near the oropharynx may increase pressure in the glossopharyngeal space, which may promote anterior displacement of the tongue and reduce airway obstruction.
  • Sampling of exhaled respiratory gases may be useful in several situations, such as when using capnography to monitor end tidal carbon dioxide (ETCO2) concentrations.
  • ECO2 end tidal carbon dioxide
  • supplemental gases delivered at or near the sampling site may dilute the carbon dioxide sample.
  • exhaled respiratory gases are sampled at the mouth opening (anteriorly relative to the oropharynx) and/or nasally.
  • Sampling at one location i.e., at the mouth
  • the patient is breathing through the other (i.e., the nose)
  • exhaled respiratory gases may be sampled near the oropharynx, which may reduce sampling inaccuracies from dead space dilution and entrainment of room air. Sampling near the oropharynx may also increase the chance of respiratory gas sampling independent of whether mouth breathing or nasal breathing is occurring.
  • the arrangement of the supplemental gas supply orifice anteriorly of the sampling port allows an exhaling patient to deliver an undiluted sample to the sampling port because exhaled respiratory gas moves anteriorly through the lateral interocclusal passageway and forces supplemental gas within the lateral interocclusal passageway(s) to be expelled anteriorly away from the sampling port during expiration, thereby increasing the accuracy of the sample by preventing dilution of the exhaled respiratory gas at the sampling port.
  • portions or all of the mouthpiece 100 may also be doped with, made of, or otherwise include a radiopaque material.
  • Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the mouthpiece 100 in determining its location.
  • Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, radiopaque bands or markers may also be incorporated into the design of the mouthpiece 100 to achieve the same result.
  • a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the mouthpiece 100 .
  • the mouthpiece 100 may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image.
  • the mouthpiece 100 may also be made from a material that the MRI machine can image successfully.
  • Some metallic materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.
  • cobalt-chromium-molybdenum alloys e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like
  • nickel-cobalt-chromium-molybdenum alloys e.g., UNS: R30035 such as MP35-N® and the like
  • nitinol and the like, and others.
  • the mouthpiece 100 may be made from or otherwise include a biocompatible polymer or polymeric material.
  • suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL®available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide
  • the polymer can be blended with a liquid crystal polymer (LCP).
  • LCP liquid crystal polymer
  • the mixture can contain up to about 6 percent LCP.
  • the anterior portion or bite block portion of the mouthpiece 100 may be formed of a stiffer or more rigid material than the posterior portion forming the lateral interocclusal passageways 116 .
  • Various combinations of hard, soft, rigid, or flexible materials may be used as desired.
  • an exterior surface of the mouthpiece 100 may be sandblasted, beadblasted, sodium bicarbonate-blasted, electropolished, etc.
  • a coating for example a lubricious, a hydrophilic, a protective, or other type of coating may be applied over portions or all of the mouthpiece 100 .
  • the interocclusal passageway may include a lubricious, hydrophilic, protective, or other similar coating disposed on an inner surface thereof.
  • Suitable lubricious polymers are well known in the art and may include silicone and the like, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, and the like, and mixtures and combinations thereof.
  • HDPE high-density polyethylene
  • PTFE polytetrafluoroethylene
  • polyarylene oxides polyvinylpyrolidones
  • polyvinylalcohols polyvinylalcohols
  • hydroxy alkyl cellulosics algins
  • a medical mouthpiece comprising:
  • a generally U-shaped member forming an upper surface configured to contact an upper dentition of a patient spaced apart from a lower surface configured to contact a lower dentition of the patient;
  • the U-shaped member forms a lateral interocclusal space extending from an anterior aperture to a posterior aperture between the upper surface and the lower surface.
  • sampling port formed within a posterior portion of the lateral interocclusal space the sampling port configured to be positioned in a posterior portion of the lateral interocclusal space of the patient;
  • a sampling conduit for fluid communication between the sampling port and an analyzing apparatus configured to analyze exhaled respiratory gases.
  • a supplemental gas conduit for fluid communication between a source of supplemental gas and a supply orifice within the lateral interocclusal space.
  • a medical mouthpiece comprising:
  • a generally U-shaped member forming an upper surface configured to contact an upper dentition of a patient spaced apart from a lower surface configured to contact a lower dentition of the patient;
  • sampling port formed within a posterior portion of the generally U-shaped member, the sampling port having a sampling orifice recessed within the posterior portion;
  • a sampling conduit for fluid communication between the sampling port and an analyzing apparatus configured to analyze exhaled respiratory gases.
  • sampling port is configured to be positioned in a posterior portion of a lateral interocclusal space of the patient.
  • a medical mouthpiece comprising:
  • a generally U-shaped member forming an upper surface configured to contact an upper dentition of a patient spaced apart from a lower surface configured to contact a lower dentition of the patient;
  • a supplemental gas conduit for fluid communication between a source of supplemental gas and a supply orifice formed in the generally U-shaped member.
  • a medical mouthpiece comprising:
  • a generally U-shaped member forming an upper surface configured to contact an upper dentition of a patient spaced apart from a lower surface configured to contact a lower dentition of the patient;
  • the U-shaped member forms a lateral interocclusal passageway extending from an anterior aperture to a posterior aperture between the upper surface and the lower surface, the lateral interocclusal passageway configured to provide a conduit for respiratory gas exchange;
  • sampling port formed within a posterior portion of the lateral interocclusal passageway, the sampling port configured to be positioned in a posterior lateral interocclusal space of the patient;
  • a sampling conduit for fluid communication between the sampling port and an analyzing apparatus configured to analyze exhaled respiratory gases
  • a supplemental gas conduit for fluid communication between a source of supplemental gas and a supply orifice within the lateral interocclusal passageway.
  • the central passageway permits access to an oral cavity of the patient for the introduction of a medical instrument therein.
  • a medical mouthpiece comprising:
  • a generally U-shaped member forming an upper surface configured to contact an upper dentition of a patient spaced apart from a lower surface configured to contact a lower dentition of the patient;
  • the U-shaped member forms a lateral interocclusal passageway extending from an anterior aperture to a posterior aperture along an axis defined by a line between the upper dentition and the lower dentition, the lateral interocclusal passageway configured to provide a conduit for respiratory gas exchange;
  • a sampling port formed within a posterior portion of the lateral interocclusal passageway
  • sampling conduit fluidly connecting the sampling port and an analyzing apparatus configured to analyze exhaled respiratory gases collected adjacent an oropharynx of the patient
  • a supplemental gas conduit fluidly connecting a source of supplemental gas and a supply orifice within the lateral interocclusal passageway.
  • a medical mouthpiece comprising:
  • a generally U-shaped first member forming an upper channel spaced apart from a lower channel with left and right lateral interocclusal passageways formed therebetween, the left and right lateral interocclusal passageways extending from an anterior portion of the first member through a posterior portion of the first member, and a first central orifice extending through the anterior portion;
  • the first member is shaped and configured to receive an upper dentition of a patient in the upper channel or a lower dentition of a patient in the lower channel;
  • the second member attached to the anterior portion, the second member including a second central orifice extending through the second member and in communication with the first central orifice to form a central passageway extending through the mouthpiece;
  • the second member includes a first port and a second port formed therein;
  • the first port being fluidly connected to a left lateral interocclusal sampling port and a right lateral interocclusal sampling port for sampling expiration gases, the left and right lateral interocclusal sampling ports being disposed within the left and right inter-occlusal passageways, respectively, proximate the posterior portion;
  • the second port being fluidly connected to the left and right lateral interocclusal passageways for delivery of a supplemental gas into the left and right lateral interocclusal passageways.
  • a method for delivering a gas to a patient comprising:
  • the mouthpiece having a generally U-shaped member forming a lateral interocclusal passageway extending posteriorly between an upper dentition and a lower dentition of the patient;
  • a supplemental gas through the supplemental gas conduit and into the lateral interocclusal passageway, the supplemental gas mixing with the gas and being delivered to the patient's posterior oropharynx.
  • the mouthpiece includes a sampling port disposed within a posterior portion of the lateral interocclusal passageway, and a sampling conduit fluidly connecting the sampling port to an analyzing apparatus, and the method further includes:
  • ETCO2 end tidal carbon dioxide
  • sampling port includes a covering disposed thereon, the covering being impermeable to liquid and permeable to gas.
  • left and right lateral interocclusal sampling ports each include a covering disposed thereon, the covering being impermeable to liquid and permeable to gas.
  • the medical mouthpiece of aspect 18, wherein the respiratory equipment is selected from a ventilator, an anesthesia circuit, a CPAP device, a BiPAP device, a rescue bag valve device, or combinations thereof.
  • a method for sampling exhaled respiratory gases of a patient comprising:
  • the mouthpiece having a generally U-shaped member forming a lateral interocclusal passageway extending posteriorly between an upper dentition and a lower dentition of the patient;
  • analyzing step includes analyzing for end tidal carbon dioxide (ETCO2) concentration.
  • ETCO2 end tidal carbon dioxide
  • the mouthpiece includes a sampling port disposed within a posterior portion of the lateral interocclusal passageway, and a sampling conduit fluidly connecting the sampling port to an analyzing apparatus, and the method further includes:

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US14/213,719 2013-03-15 2014-03-14 Medical breathing apparatus Active 2036-01-31 US9888867B2 (en)

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US10010266B2 (en) 2018-07-03
AU2014228824B2 (en) 2016-09-08
AU2014228824A1 (en) 2015-10-08
CN105246535A (zh) 2016-01-13
WO2014144717A2 (fr) 2014-09-18
EP2968814A2 (fr) 2016-01-20
US20140276170A1 (en) 2014-09-18
EP2968814B1 (fr) 2017-09-27
CN105246535B (zh) 2018-03-20
WO2014144717A3 (fr) 2014-11-27

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